# K241451: Rusch Endotracheal Tubes (Reinforced); Rusch Endotracheal Tubes (Safety Clear); Rusch Endotracheal Tubes (Safety Clear Pediatric)

- Pathway: 510(k) (Traditional)
- Applicant: Teleflex Incorporated
- Decided: Feb 11, 2025 after 265 days
- Product code: BTR (Tube, Tracheal (W/Wo Connector))
- Device class: 2
- Regulation: 21 CFR 868.5730
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K961837 (1996). 3 ancestors in all.
No later device cites it as a predicate yet.
2 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990619: Rusch Reinforced Endotracheal (or Tracheal) Tube- Cuffed and Uncuffed Murphy/Magill, Sterile, Rusch Intl. (1999) Summary page 6.
- K961837: Rush Oral/Nasal Tracheal Tube Cuffed Magill/Murphy, Rusch Intl. (1996) Summary page 6.
- K993786: Rusch Oral/Nasal (Safety Clear Plus) Tracheal Tube Cuffed, Magill/Murphy, Rusch Intl. (2000) Summary page 6.

## Indications for use
Reinforced Tube: Rusch Reinforced Endotracheal Tubes are designed for oral or nasal intubation and are indicated for airway management. The correct designation (oral, nasal or oral/nasal) is printed on the tube and unit package. Reinforced Endotracheal Tubes may be used to reduce the potential for kinking whenever an unusual positioning of the head or neck is required following intubation. The Reinforced Endotracheal Tubes are intended to be used on all patients requiring ventilation, pediatric and adult. Safety Clear and Safety Clear Pediatric Tubes: Rusch Endotracheal Tubes, Cuffed and Uncuffed, with or without Murphy Eye are for oral or nasal intubation. They are indicated for airway management. The Rusch Endotracheal Tubes are intended to be used on all patients requiring ventilation, pediatric and adult.

Source page: https://510kreport.com/device/K241451
Methodology: https://510kreport.com/methodology